FDA accepts Adamis NDA resubmission
The FDA has accepted for review Adamis Pharmaceuticals’ (NASDAQ:ADMP) NDA for its Epinephrine Pre-filled Syringe (PFS) product candidate for the emergency treatment of anaphylaxis.
Filed last Dec. 15, the resubmission is intended to address the issues raised by the FDA in its June 2016 complete response letter (CRL). The FDA indicated that it considered the resubmission to be a complete response to the CRL.
Adamis’ PFS is designed as a lower cost alternative to market leading auto-injectors. The PFS provides a single-dose of epinephrine, which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, foods (such as nuts), drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis.